EXCLUSIVE: Adial Pharmaceuticals Secures FDA End of Phase 2 Meeting Request To Discuss Upcoming Clinical Development Plan For Lead Program

Adial Pharmaceuticals, Inc. ADIL on Thursday announced that the FDA has granted the company's request for an End of Phase 2 meeting to discuss its proposed clinical development plan and seek the U.S. Food and Drug Administration (FDA) guidance on the Phase 3 clinical trial for AD04.

The meeting will take place on July 25, 2025. AD04 is the company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 8 drinks/day).

Also Read: EXCLUSIVE: Adial Pharmaceuticals Expands Patent Portfolio With New US Patent For Lead Drug For Alcohol And Opioid Use Disorders

Cary Claiborne, President and Chief Executive Officer of Adial, commented, "We recently announced the successful results of our Type D Meeting with FDA, confirming Adial's 505(b)(2) regulatory bridging strategy. Concurrently, we have made strong progress in developing the design of our Phase 3 trial and look forward to aligning with the FDA on key requirements to move AD04 forward. Our recent analyses have reinforced the selection of our target patient population and continue to support AD04's potential to effectively treat AUD and related conditions. We remain confident in the path ahead and look forward to sharing a comprehensive update following our FDA meeting in July."

In February, Adial Pharmaceuticals announced a positive response from the FDA regarding its proposed in vitro bridging strategy for AD04.

The FDA's feedback follows Adial's submission in November 2024, in which the company sought the agency's guidance on aligning its AD04 formulation strategy and bridging approach.

With this regulatory confirmation, Adial is manufacturing clinical supply materials in preparation for its upcoming Phase 3 program in 2025.

Adial Pharmaceuticals announced that patent number 12,221,654 was issued by the United States Patent and Trademark Office on February 11, 2025.

The patent expands the covered methods of identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04, the company's investigational new drug product.

Price Action: ADIL stock traded lower by 3.31% to $0.63 premarket at the last check on Thursday.

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